Product Development Quality Leader

Zoetis’s Veterinary Medicine Research and Development (VMRD) Product Quality group is seeking highly skilled, detail-oriented, and forward-thinking

Quality Leaders who will be active members of vaccine, biopharma and pharma co-development teams providing input on co-development strategy (clinical/PK supplies, design of experiments, analytical method development and transfer, registration batch manufacture, submission planning, etc.) throughout the lifecycle of a project including transfer to Zoetis Global Manufacturing & Supply (GMS).

Their goal will be to assure that long-term product sustainability is a process design deliverable by guiding co-development teams with a quality mindset. Knowledge from product and process development is the basis for establishing an approach to control of the manufacturing process that results in products with the desired quality attributes. The Quality Leaders will help to ensure that during process/product development, variation, impact of variation and control of variation is understood and well documented.

The successful candidate will make sure that the appropriate level of quality and compliance is applied across all aspects of the process design stage of process validation, collaborating with both VMRD and GMS. Quality Leaders will be involved in key decision making and supportive processes of the co-development team such as risk assessments, determination of Critical Process Parameters, Critical Quality Attributes (specifications) and control strategies.

The close partnership with GMS will continue across the qualification and verification phases of validation to ensure seamless transition of product quality to commercial manufacturing.

The Quality Leaders will foster a culture of excellence and harmonize practices across diverse projects. They will be responsible for the review and approval of GMP documentation (batch records, protocols, reports, stability, etc.) for each project and for the maintenance and continuous improvement of the VMRD Quality Management System policies in accordance with regulatory requirements, Zoetis standards and industry best practices.

Each Quality Leader will be responsible for supporting multiple projects and interfacing with partner groups in the co-development teams across the organization in both VMRD and GMS. These include global development teams, regulatory, GMS quality, formulation, chemistry, analytical, bioprocess development, PK/PD, clinical, CROs, etc.

Expectation that colleague will adhere to being present on-site ≥50% of the time

Responsibilities:

• As part of the core co-development team, represent VMRD Product Quality through product development. Provide strategic input and participate in highly matrixed cross-functional teams with operational leaders to prioritize processes and roadmaps and drive innovation. Collaborate to develop and implement innovative solutions to improve business processes, reduce compliance risk, while driving efficiency.
• Interpret and stay updated on relevant regulation and guidelines from health authorities.
• Ensure that all processes, documentation, facilities, and products comply with requirements. Assure adherence to appropriate GMP practices with a forward-looking perspective to anticipate and address emerging challenges across the business lines.
• Ensure a proactive and adaptive approach to evolving project needs. Champion the implementation of efficient and compliant processes. Foster a culture of quality and continuous improvement.
• Use a quality-embedded mindset and practical knowledge of industry, customer requirements, and general business environment to define appropriate actions.
• Operate within quality management systems to lead, own, and drive investigations, corrective/preventive actions, and change control activities in the design phase
• Partner with Quality Operations in GMS during the qualification and verification phases of product lifecycle to ensure a seamless approach to process transfer and to knowledge management.
• Identify opportunities for automation and integrating technological solutions to simplify compliance tasks and improve quality.
• Demonstrate resilience in the face…